Abortion in First Trimester
Conditions
Brief summary
The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum aspiration (EVA). The investigators hypothesize that operative times will be increased when using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Between 10 0/7 and 13 6/7 weeks of gestation * Documented intra-uterine pregnancy * Presenting for surgical induced abortion at RHS * English-speaking * Age 18 or older
Exclusion criteria
* Spontaneous abortion * Failed medical abortion * Multiple gestation * Uterine anomalies * Lower uterine segment or cervical myomas * History of 3 or more prior cesarean deliveries * BMI \> 40 * Having the abortion procedure performed by a provider who does not perform MVA and EVA between 10 0/7 and 13 6/7 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Perioperative | Time from cannula insertion until completion of uterine evacuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure | Perioperative | — |
| Patient acceptability | Perioperative and 2 weeks postoperatively | 1\) Satisfaction with procedure on 4-point rating scale 2) Would choose same procedure again (binary response) 3) Would recommend procedure to a friend (binary response) |
| Provider acceptability | Perioperative | 1\) Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response) |
Countries
United States